Dissection of AortaNCT07742592
Retrospective Real-World Data Collection of the Conformable GORE® TAG® Thoracic Endoprosthesis When Used in Frozen Elephant Trunk Procedures for Treatment of Aortic Aneurysms and Dissections
An observational study of Dissection of Aorta and Aneurysm Aortic, run by W.L.Gore & Associates.
Trial summary
Retrospective, multicenter, single-arm registry data collection designed to characterize outcomes in patients treated with the Conformable GORE® TAG® Thoracic Endoprosthesis deployed in an antegrade fashion as part of a frozen elephant trunk (FET) procedure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dissection of Aorta, Aneurysm Aortic, Frozen Elephant Trunk
- What is being tested?
- Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient pool from which sites will screen for enrollment is comprised of patients with history of thoracic aortic disease that required surgical repair using a FET procedure. For qualifying patients with dissections, they will be enrolled into either of the following cohorts: * Hyperacute: onset of symptoms must be documented to be <24 hours prior to the date of the procedure. * Acute: onset of symptoms must be documented to be 1-14 days prior to the date of the procedure. * Subacute: onset of symptoms must be documented to be 15-90 days prior to the date of the procedure. * Chronic: onset of symptoms must be documented to be more than 90 days prior to the date of the procedure. Those patients who meet all inclusion and no exclusion criteria, will be eligible for enrollment in this retrospective study.
Who may be able to join
- Treated for aneurysm or dissection using antegrade deployed Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG) device at least 12 months prior to date of enrollment.
- Age ≥ 18 years at the time of the index procedure.
- Proximal extent of the Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG) device is sutured to the aorta and/or distal aspect of the surgical graft.
- Informed Consent Form (ICF) is signed by the subject or a legally authorized representative, or a waiver of consent is granted by the IRB of record and appropriately documented by the enrolling site.
Who cannot join
- Any modification performed on the CTAG Device, excluding suturing.
- Procedure performed in the setting of infection requiring treatment with parenteral anti-infective medication.
- Pregnant at the time of the index procedure.
- Aneurysm or Subacute / Chronic Dissection cases (onset of symptoms ≥15 days prior to the date of the procedure) with documented aortic rupture at the time of the index procedure.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Retrospective, multicenter, single-arm registry data collection designed to characterize outcomes in patients treated with the Conformable GORE® TAG® Thoracic Endoprosthesis deployed in an antegrade fashion as part of a frozen elephant trunk (FET) procedure
Read the detailed description
Retrospective, multicenter, single-arm registry data collection designed to characterize outcomes in patients treated with the Conformable GORE® TAG® Thoracic Endoprosthesis deployed in an antegrade fashion as part of a frozen elephant trunk (FET) procedure and to assess the safety and performance of the Conformable GORE® TAG® Thoracic Endoprosthesis deployed antegrade as part of a FET procedure. This will be evaluated using real-world data and Computed Tomography (CT) imaging abstracted through retrospective chart review.
- Conditions
- Dissection of Aorta, Aneurysm Aortic, Frozen Elephant Trunk
- Being tested
- Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure
- Keywords
- frozen elephant trunk, aortic aneurysm, Aortic Dissection
- Medical subject headings
- Aortic Dissection, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedureDevice
Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure
| Study group | Role | What they receive |
|---|---|---|
| Chronic/Subacute Dissections and Aneurysms | Chronic/Subacute Dissections and Aneurysms Receives: Device: Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure | |
| Acute/Hyperacute Dissections | Acute/Hyperacute Dissections Receives: Device: Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAE freedom within one year (365 days) post-implant
The primary endpoint will be measured as freedom from the composite of the following major adverse events (MAE) occurring within one year (365 days) post-implant:
- Permanent Stroke
- Permanent Paraplegia/ Paraparesis
- Mortality
- Reoperation
Measured: From date of index procedure through 365 days post implant
Secondary outcomes (1)
Freedom from imaging outcomes within the 12-Month analysis window
The secondary endpoints will be measured as freedom from each of the following imaging outcomes within the 12-Month analysis window unless specified:
- Failed Patency (within one year (365 days) post-implant)
- Pseudoaneurysm (within one year (365 days) post-implant)
- Increase in Aortic Diameter
- Device Integrity
- Device Migration
- Type IA Endoleak
- Type IB Endoleak
- Type III Endoleak
- Thrombosis of Index Pathology
Measured: From the date of the index procedure through end of 12 months analysis window unless otherwise specified
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dissection of AortaStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742592
- Sponsor's protocol ID
- TAG 25-09
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Real-World Data Collection of the Conformable GORE® TAG® Thoracic Endoprosthesis When Used in Frozen Elephant Trunk Procedures for Treatment of Aortic Aneurysms and Dissections
- ClinicalTrials.gov ID
- NCT07742592
- Acronym / sponsor ID
- TAG 25-09
- Conditions
- Dissection of Aorta, Aneurysm Aortic, Frozen Elephant Trunk
- Keywords
- frozen elephant trunk, aortic aneurysm, Aortic Dissection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective, multicenter, single-arm registry data collection designed to characterize outcomes in patients treated with the Conformable GORE® TAG® Thoracic Endoprosthesis deployed in an antegrade fashion as part of a frozen elephant trunk (FET) procedure
Detailed description
Retrospective, multicenter, single-arm registry data collection designed to characterize outcomes in patients treated with the Conformable GORE® TAG® Thoracic Endoprosthesis deployed in an antegrade fashion as part of a frozen elephant trunk (FET) procedure and to assess the safety and performance of the Conformable GORE® TAG® Thoracic Endoprosthesis deployed antegrade as part of a FET procedure. This will be evaluated using real-world data and Computed Tomography (CT) imaging abstracted through retrospective chart review.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic/Subacute Dissections and Aneurysms | – | Device: Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedureChronic/Subacute Dissections and Aneurysms |
| Acute/Hyperacute Dissections | – | Device: Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedureAcute/Hyperacute Dissections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient pool from which sites will screen for enrollment is comprised of patients with history of thoracic aortic disease that required surgical repair using a FET procedure. For qualifying patients with dissections, they will be enrolled into either of the following cohorts: * Hyperacute: onset of symptoms must be documented to be <24 hours prior to the date of the procedure. * Acute: onset of symptoms must be documented to be 1-14 days prior to the date of the procedure. * Subacute: onset of symptoms must be documented to be 15-90 days prior to the date of the procedure. * Chronic: onset of symptoms must be documented to be more than 90 days prior to the date of the procedure. Those patients who meet all inclusion and no exclusion criteria, will be eligible for enrollment in this retrospective study.
Key inclusion criteria (4 listed)
- Treated for aneurysm or dissection using antegrade deployed Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG) device at least 12 months prior to date of enrollment.
- Age ≥ 18 years at the time of the index procedure.
- Proximal extent of the Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG) device is sutured to the aorta and/or distal aspect of the surgical graft.
- Informed Consent Form (ICF) is signed by the subject or a legally authorized representative, or a waiver of consent is granted by the IRB of record and appropriately documented by the enrolling site.
Key exclusion criteria (4 listed)
- Any modification performed on the CTAG Device, excluding suturing.
- Procedure performed in the setting of infection requiring treatment with parenteral anti-infective medication.
- Pregnant at the time of the index procedure.
- Aneurysm or Subacute / Chronic Dissection cases (onset of symptoms ≥15 days prior to the date of the procedure) with documented aortic rupture at the time of the index procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedureAntegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure | Device | Acute/Hyperacute Dissections, Chronic/Subacute Dissections and Aneurysms |
Primary outcome
MAE freedom within one year (365 days) post-implant
Time frame: From date of index procedure through 365 days post implant
The primary endpoint will be measured as freedom from the composite of the following major adverse events (MAE) occurring within one year (365 days) post-implant: * Permanent Stroke * Permanent Paraplegia/ Paraparesis * Mortality * Reoperation
1 secondary outcome
Freedom from imaging outcomes within the 12-Month analysis window
Time frame: From the date of the index procedure through end of 12 months analysis window unless otherwise specified
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Dissection of Aorta and Aneurysm Aortic, run by W.L.Gore & Associates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harrison Lead Clinical Study Manager (12068225653, hkelner@wlgore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAE freedom within one year (365 days) post-implant (time frame: From date of index procedure through 365 days post implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.